MK0767 in Metabolic Syndrome-Dyslipidemia (0767-016)

A Multicenter, Double-Blind, Randomized, Placebo and Active-Controlled, Parallel Study to Evaluate the Lipid Altering Efficacy and Safety of MK0767 in Patients With Metabolic Syndrome and Dyslipidemia

This is a clinical trial in patients with Metabolic Syndrome and Dyslipidemia to study the effects of MK0767 on triglycerides.

Study Overview

• Status: Terminated
• Conditions: Metabolic X Syndrome Dyslipidemia
• Intervention / Treatment: Drug: MK0767; Drug: Comparator: fenofibrate; Drug: Comparator: Placebo (unspecified)

• Study Type: Interventional
• Enrollment (Actual): 436
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with Metabolic Syndrome and Dyslipidemia age 21 to 65
• Patients will be eligible for the study if their triglyceride levels are within protocol specified range and have at least 2 of the criteria for Metabolic Syndrome as defined by NCEP

Exclusion Criteria:

• Patients with a history of diabetes mellitus, partial ileal bypass, intolerant to fibric acid derivatives, requiring continuous oral corticosteroids, taking anti-seizure medications, documented coronary heart disease, renal insufficiency, proteinuria, viral hepatitis, cholelithiasis or other gallbladder disease, pancreatitis, neoplastic disease
• Patient is on cyclical estrogen medications
• Patient has taken lipid-lowering agents including fibric acid derivatives, bile acid sequestrants, HMG CoA reductase inhibitors and nicotinic acid derivatives within 8 weeks or probucol within 1 year of prior to visit 2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; MK0767; 2.5 mg/day	Drug: MK0767; MK0767 2.5, 5, and 10 mg/day supplied as tablets
EXPERIMENTAL: 2; MK0767; 5mg/day	Drug: MK0767; MK0767 2.5, 5, and 10 mg/day supplied as tablets
EXPERIMENTAL: 3; MK0767; 10 mg/day	Drug: MK0767; MK0767 2.5, 5, and 10 mg/day supplied as tablets
ACTIVE_COMPARATOR: 4; fenofibrate 200 mg	Drug: Comparator: fenofibrate; fenofibrate 200 mg supplied as capsules
PLACEBO_COMPARATOR: 5; Matching Placebo	Drug: Comparator: Placebo (unspecified); matching placebo will be supplied as tablets/capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
a dose-response will be seen across the doses of MK0767 and placebo in lowering fasting triglyceride.	After 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
MK0767 will be safe and well tolerated	throughout study and at 12 weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (ACTUAL): December 1, 2003
• Study Completion (ACTUAL): December 1, 2003

Study Registration Dates

• First Submitted: June 20, 2008
• First Submitted That Met QC Criteria: June 20, 2008
• First Posted (ESTIMATE): June 23, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 12, 2015
• Last Update Submitted That Met QC Criteria: June 11, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Lipid Metabolism Disorders; Syndrome; Metabolic Syndrome; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Fenofibrate
• Other Study ID Numbers: 0767-016; MK0767-016; 2007_641